US Drug Recall Register
Class III · Low risk Terminated Initiated May 24, 2017 (9 years ago)

Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules

What was recalled

Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30

Recalling firm
Shionogi Inc.
NDC code
66993-070-30
Origin
GA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0219-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.